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Recall Observatory FDA recall evidence

Device product

2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Plating System for trauma and reconstructive procedures of small bones.

Z-2738-2015

July 31, 2015

Class II

Product summary

Firm
Trilliant Surgical Ltd.
Event
Event 71936
Status
Terminated
Classification
Class II
Quantity
108 units
Official record key
device-enforcement:Z-2738-2015

Official wording

Reason: Gridlock screw driver bits for the Gridlock Plating System were identified to be out of specification and have the potential for shallow engagement between the driver and the screw, resulting in an increased likelihood of stripping screw heads intraoperatively. Specifically, the minor diameter of the drive feature is above the specification, potentially reducing the engagement between the driver and the screw head.

Code information: TSL002605

Distribution pattern: NY, OH, CA, SC, NJ, AZ, VA, IN, FL, MN, OK, AR, MO, WI, GA, SD, IA, IL, TX

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification